Friday, January 19, 2018

Sexism stunts medical progress

http://daily-iowan.com/2018/01/18/rosario-sexism-stunts-medical-progress/

Rosario: Sexism stunts medical progress

Unrest, a new documentary, explores the stigma surrounding chronic
fatigue syndrome.
Isabella Rosario
Jan 18, 2018

isabella-rosario@uiowa.edu

Last semester, I began experiencing unrelenting fatigue and muscle
pain like I had never felt before. For weeks, I could barely go to
class or even stand to do the dishes. I begrudgingly made an
appointment at UI Student Health & Wellness.

The day before my appointment, I went down the rabbit hole of Googling
my symptoms. One result I came across was chronic fatigue syndrome.
When I brought up the possibility of the condition at my appointment,
the doctor chuckled and told me that it was not a real illness. He
said my symptoms were most likely the physical manifestation of
depression or anxiety — i.e., it was all in my head. He gave me a
handout for University Counseling Service and sent me on my way.

Soon after, I visited my primary-care doctor back home, tested
positive for pneumonia, and was promptly given antibiotics. So much
for "all in my head."

Fast forward to last week's PBS release of Unrest, a documentary by
Jennifer Brea. She was a Harvard Ph.D. student preparing for her
upcoming wedding when she was struck with a high fever. After the
fever broke, Brea experienced dizziness, recurrent infections, and
debilitating neurological symptoms. Her neurologist diagnosed her with
conversion disorder. He said Brea's physical symptoms were in response
to some psychological trauma she may not even remember.

Brea was eventually diagnosed with myalgic encephalomyelitis, more
commonly known as chronic fatigue syndrome — a very real illness twice
as common as multiple sclerosis and recognized by the World Health
Organization since 1969. Directing from her bed, Brea interviews
people from around the world with the condition, which causes fatigue
that does not improve with rest, memory problems, widespread pain, and
more symptoms that range in severity; 25 percent of sufferers are
either housebound or bedbound for long periods. And yet, they are
continually dismissed and disbelieved by doctors who psychologize
their symptoms—especially if they are women.

I hadn't heard of conversion disorder prior to my appointment at
Student Health, or at least I thought I hadn't. It was originally
called hysteria, which Plato described as women's uteruses "blocking
passages, obstructing breathing, and causing disease." In the 19th
century, Freud dropped the uterus component and instead theorized that
people could subconsciously convert psychological pain into physical
symptoms — which is exactly how my first doctor explained my symptoms.
Today, hysteria — renamed "conversion disorder" — is diagnosed two to
10 times more in women than in men.

And so it comes as no surprise to me that ME/CFS — an illness two to
four times more common in women — is not taken seriously by the
medical community. It comes as no surprise to me when I hear stories
from female friends who have had doctors dismiss their fevers or
coughs as stress-related. Multiple sclerosis was diagnosed as
hysterical paralysis until CAT scans revealed brain abnormalities. Why
are we repeating this narrative with ME/CFS almost 50 years into its
recognition by the World Health Organization? Why is it that when
doctors do not immediately have the answers, they assume an absence of
biological cause?

I do not believe the medical community is full of raging sexists.
Rather, my experience and viewing of Unrest illustrated to me how
incredibly human doctors are — how they are susceptible to unconscious
biases and sexism in the same way all of us are. And how they, in
congruence with society, would rather offer easy explanations for the
unfamiliar.

As we embark on a new semester, I hope we can open our minds to the
diversity of others' experiences and the class material presented to
us. With persistent curiosity, our generation can be the one that
looks deeper than hysteria and other flawed explanations for what we
do not yet understand.

Tuesday, January 16, 2018

NIH Striving to Avoid False Hope

https://www.medpagetoday.com/publichealthpolicy/publichealth/70529

NIH Striving to Avoid False Hope in Chronic Fatigue

Director Francis Collins, MD, PhD, talks about his agency's priorities

by Joyce Frieden, News Editor, MedPage Today January 16, 2018

BETHESDA, Md. -- The National Institutes of Health is trying hard to
bring real hope -- not false hope -- to patients with myalgic
encephalomyelitis/chronic fatigue syndrome (ME/CFS), NIH director
Francis Collins, MD, PhD, said during an exclusive interview with
MedPage Today.

"Five years ago ... there was this big excitement that there was a
retrovirus that was turning up in people with CFS, and initially it
didn't appear to be in people who were unaffected," Collins said
Friday during an interview at the NIH main campus, at which a
communications staff member was present. "It was a funny retrovirus
that had only been seen in cultured cells in the lab, and maybe in
mice, [and it was] called XMRV."

"It was really exciting because it was a retrovirus, and we have drugs
for retroviruses! It got published in Science to great excitement, but
then almost immediately other researchers looking at very similar
patients said, 'We don't see this' or maybe 'We see it in people who
don't have the disease,'" he continued. "We mounted a careful
multi-site study funded by NIH with blinded samples to try to see
[whether] this [held] up and sadly, it did not. That was such a blow
to a community of suffering people who thought, 'Finally, they're on
to something.'"

Collins said he has been "greatly moved and troubled" by the stories
of CFS patients, "especially when many of those stories start with
people who are highly active, and many of them fairly athletic, and
some illness that sounds viral, like a really bad flu, hits them, but
they don't get better ... Many of them are unable to resume normal
activities and end up bedridden for months or years."

In September, NIH awarded $7 million in grants to three clinical
centers and a data coordination center to continue ME/CFS research.
"Some people have said, 'Your three centers are all doing the same
things,'" he added. "Yeah, that's intentional; we want to see
immediately if something looks like it's promising, is it promising
really, or another false positive? We've had too many of those and we
don't want to make that mistake again."

In addition, "I moved the program out of the place it was at NIH,
which was at the Office of Research on Women's Health," he said. "It
is true that women are affected more than men, but that was seen as
not a particularly important place for an important disease to be."

Collins asked Walter Koroshetz, MD, director of the National Institute
of Neurological Disorders and Stroke (NINDS), to head up the NIH's
research effort, and NINDS senior investigator Avi Nath, MD, "to start
a protocol in our clinical center to bring people with this disease
for an intense 1 or 2 weeks of just looking at every possible cause.
And that's led to a big uptick in the amount of research that's going
on."

Although the medical community has been criticized for not taking
ME/CFS seriously, "it's very hard for me to see how [that criticism
is] fair when you hear stories of people who've gone rather suddenly
from a full life to bedridden status -- something dramatic happened
there," said Collins.

He added, however, that "there are problems [in that] CFS has become
such a blurry diagnosis, that in there amongst hundreds of thousands
or millions of people who carry that diagnosis is a whole
heterogeneous group and there may be individuals ... who have
something else entirely or even people who are suffering from
depression and are therefore feeling fatigue for that [reason]. I
think that's added to the difficulty that the medical care system has
had coming to grips with this as a real disease that has a desperate
need for new treatments."

Thinking Big on Cancer Cures

Collins also expressed excitement over the additional funding --
granted under the 21st Century Cures Act -- that his agency will have
for the "cancer moonshot" project. "We're thrilled to have the
opportunity to push this even faster," he said. "It builds upon a
foundation of cancer research that's been going on for a long time ...
[It gives us] about $1.6 billion over 6-7 years to add to what was
already available for cancer research."

What is NIH doing with that money? "We convened 2 years ago a group of
highly expert cancer research visionaries -- from academia, the
private sector, and advocacy [groups] -- and said, 'OK, guys, what do
we need to do that we're not already doing? Think big, think bold;
don't worry about risky projects if they can pay off,'" he explained.
"They provided a blueprint of where we needed to go, a series of about
28 initiatives. Those have been our guiding documents to crank this
up."

Immunotherapy is one of the big areas the researchers are focusing on,
he continued. "You can't help but look at some of the amazing success
stories of cancer immunotherapy of people who had widely metastatic
disease and are now cured without going, 'Wow, we are really onto
something!' -- after all of these years of trying to figure out
whether this could work. For leukemias that used to be refractory, and
with lymphomas that failed chemotherapy, immunotherapy is looking
really good."

"The challenge is, how do we take those successes and expand the
success rate to solid tumors where this just really hasn't paid off
yet -- pancreatic cancer, colon cancer that's already metastasized,
breast cancer, prostate cancer?" Collins said. "But cancers are very
clever and they hide their abnormal proteins, telling the immune
system, 'There's nothing to see here.'"

"So we have to help the immune system recognize trouble, and that's
led to a host of these really dramatic new technologies like CAR-T
cells, now approved for two different applications by FDA but still
not yet for solid tumors; that's the big frontier. But it ought to be
possible to do that ... and that's where a lot of the moonshot money
is going."

Working with Commercial Partners

One way to speed up these therapies is partnership with industry, he
said, "but they have the same frustrations about why it doesn't work
... So we need to have a better biological understanding of that
process, basically biomarkers that will be predictive of whether a
particular immunotherapy is going to be successful or not. We don't
have those."

"After talking to industries that are most engaged over the course of
more than a year, this has developed into a formal partnership: the
Partnership for Accelerating Cancer Therapies, in which 11 companies
all agreed to take part and contribute $5 million each ... so they're
putting money on the table, and partnering with NIH with a very
explicit set of goals," Collins said. That partnership launched in
October.

As great as some of the new therapies are, sometimes they stop working
after 9-12 months, so researchers want to know "What's the mechanism
of resistance, and how can we avoid it?" said Collins. "Do we need to
do the same thing we do with HIV or tuberculosis -- hit them with two
or three drugs at once instead of one at a time? Cancer may have that
same propensity to develop resistance if you don't have that full army
at work, so combination therapy is very much of interest as well."

As for the word "moonshot," "It is helpful to have something that
people can immediately identify -- 'Oh, that's what you're talking
about!'" he said. "And if it sounds inspiring, exciting, promising,
that's even better. There were discussions about whether that's the
best label, but that's what [former Vice President Joe Biden] wanted,
and it's in the legislation, so I guess we're going to stick with it."

Precision Medicine ... for All of Us

Another term that gets a lot of discussion at NIH is "precision
medicine." Collins recalled that he wrote a book in 2010 called The
Language of Life: DNA and the Revolution in Personalized Medicine.
"That was the term I was using at that point."

"Then there was a National Academies [report] that looked at the
promise of all this," he said. "They didn't like 'personalized
medicine' because they thought it sounded like every decision, every
drug is going to be just for that one person, as opposed to
recognizing that if you take a million people, maybe for 50,000 of
them this is going to work and 30,000 need something else. So ... they
liked 'precision' better. That's the idea of taking a
one-size-fits-all approach, which most of medicine has been, and using
all the data available to be more precise about what's going to work
for that particular person."

"Ultimately, of course, one wants it to mean that all of us have a
perfectly designed program for preventing illness that we can follow
and it will keep us healthy, and if we're still unlucky enough to get
sick, there's a precise intervention available that's going to make us
better," Collins said. "And that is the goal -- I will not step away
from that goal, but we're certainly not at a point where we can claim
that's the case."

However, because the current initiative involves a nationwide program
that the NIH is trying to get a million people to join, "I don't think
we want to call it the 'Precision Medicine Initiative' -- we've got to
have a name that's more descriptive of what we're trying to do,
[which] is to learn as much as we can from as many willing partners as
we can. [So the name is] 'All of Us,' and I think we've done a good
job of branding it that way."

"A secondary meaning [is] 'all about us' in terms of of our medical
experiences, environmental exposures, diet, exercise, things we care
about, and things we don't care about," he continued. "We want those
million people to feel like they have embraced this program, that they
want it to succeed ... that they're going to get a lot of information
back about themselves, and that they're excited to be part of this
national adventure."

Collins is hoping that the results of the initiative won't take
decades to implement in practice. "One thing that will help here is
that at least half of the enrollees, as we currently imagine it, are
going to be involved in health provider organizations that are both
helping them engage in the research but are also their caregivers."

"That setup will be particularly relevant as far as getting access to
electronic health records, blood samples, their history of
medications, and so on, because they have those systems in place," he
said. "But we want everybody in the United States to be able to take
part if they want to, so there's also a direct volunteer pathway for
somebody who doesn't happen to be in one of those health provider
organizations, to call an 800 number, or go to the Web and sign up and
also get involved."

"We are very determined to make this a highly diverse million people,
in terms of age, gender, geography, race, ethnicity, and socioeconomic
status -- we want this to be the kind of view of the nation that will
also teach us things about health disparities."

Part of that work involves encouraging minorities to participate,
which has been an issue in the past, Collins said. "We've worked
really hard on trying to understand the reasons why that has been the
case, and how this project could be presented in a way that is
different."

"We've brought on board a chief engagement officer, Dara
[Richardson-Heron, MD], an African-American woman, and she has been
fantastically wise about how to build those relationships in a
trusting way, and recognizing this doesn't have an easy history and we
need to be totally aware of that," he said. Part of the outreach
involves working with community health centers, whose patients are
typically of lower socioeconomic status, to encourage those patients
to participate.

To ensure that the All of Us project will launch properly, NIH has
been beta testing it since last May, Collins noted. "We've enrolled
over 10,000 people as test subjects to see whether the questionnaires,
the access to electronic health records, the security systems, the
blood samples -- whether everything is moving the way it should as we
bring online all these enrollment centers all over the country ... and
it's looking really good." As for a launch date, "We're saying in the
spring -- maybe by next month we'll be at the point of being able to
settle on a [specific] date."

Making sure the participants reap the benefits from the study --
especially if it results in high-priced treatments -- is an issue, he
said. "We can't, with this one study, solve [the problems of] our
healthcare system."

Collins noted that a New York Times article pointed out that Congress
seems interested in supporting research studies but can't agree on how
to make sure people have access to healthcare. "We can't solve that
but we can certainly try to provide for people to have access to this
study, which is going to give them information back about themselves."

Monday, January 15, 2018

Unrest is on Netflix

Jennifer Brea:

The time is here! Unrest is now available on @Netflix! Grab your
popcorn, grab your friends, and get ready to stream now on your
computer, smartphone, or TV. https://www.netflix.com/title/80168300
#UnrestFilm #UnrestNetflix

UNREST is now on Netflix

What??? We are on Netflix? That's right.
You can now tell your family and friends that all they have to do to watch Unrestis log onto Netflix and hit play!
We are (or will be) available in 190 countries around the world and twenty languages. This means even more people can see the film and join the movement for equal access to research, treatment and care.
But being on Netflix doesn't guarantee views. And watching Unrest is only the beginning. To transform awareness into action, we need to organize! Here are three ways you can help.
 

SHARE ON SOCIAL

Shout our Netflix launch from the rooftops. Share on your social networks and let's get our stories seen and heard! You can find images and sample tweets in our social press kit.

WATCH AND LEAVE A REVIEW


Watch Unrest again or leave a review. We'd love to get Unrest into Netflix's "Trending Now" section today so casual browsers can stumble upon it and take a look. Views and reviews help. We can do it – with your help!
 

ORGANIZE A HOUSE PARTY


There's still time to sign up and organize a house party to educate friends and family, and take action together. And now with Unrest's availability on Netflix, it's never been easier!
Watch on Netflix
Don't have Netflix? US residents can still watch Unrest for free on PBS's Independent Lens website through January 22nd or go here for even more ways to watch.

We've come so far together – and this is JUST the beginning. Thank you for your support, your sharing, and your activism. Together, we can change the world.

Jennifer Brea & The Unrest Team
 
P.S. - Are you ready to show everyone it's #TimeForUnrest by wearing a shirt, hoodie, button, or sporting a tote? Why not grab a poster while you're at it? But hurry-- Unrest merchandise is selling quick! All proceeds from our store help to sustain our global campaign.

Sunday, January 7, 2018

Farewell – A Last Post from Anne Örtegren

A ME/CFS patient explains her assisted suicide

http://lobel.nu/anne.html


Unrest -- patients demanding justice

"This is a much more serious disease than many of the other things that people are worried about. It's more common than MS, it's more common than Parkinson's disease, it's more common than Aids. This is probably the last major disease that we know so little about. And it's because of its nature that it's been hidden. The severe patients are often just in their home being looked after by someone and no one knows they exist. But it can get very severe, people have tried to make some measures in terms of debilitating illness, it's generally viewed as worse than many other diseases that have been ranked in terms of quality of life.''

http://www.independent.co.uk/news/long_reads/why-patients-me-demanding-justice-millions-missing-chronic-fatigue-illness-disease-a8133616.html

Sunday, December 31, 2017

A Controversial Therapy For ME Has Led To Claims Of Death Threats, Harassment, And Pseudoscience

"Telling people who have a debilitating condition such as ME that it's all in our minds, and that we should try harder. I'm the last person in the world who should try harder. That's where it's totally wrong."




https://www.buzzfeed.com/tomchivers/inside-the-controversial-therapy-for-chronic-fatigue?utm_term=.dspm87RbX#.epBQYAXzM

A Controversial Therapy For ME Has Led To Claims Of Death Threats,
Harassment, And Pseudoscience

A recent scientific trial has led to acrimonious debates over chronic
fatigue syndrome, aka ME, and boosted interest in a secretive therapy
that some call a "cult" and others call a "miracle". BuzzFeed News
investigates.

Posted on December 30, 2017, at 1:01 a.m.
Tom Chivers


The publication of a new scientific study does not usually bring about
accusations of libel, alleged death threats, and unprofessionalism.

But in the last three months, a trial into a strange, divisive therapy
for a mysterious illness has sparked exactly that – as well as
boosting interest in the therapy itself, the Lightning Process, a
controversial, much-hyped, and much-despised programme that devotees
describe as a miracle and detractors call a pseudoscientific cult.

The Lightning Process has gained attention for claiming to alleviate
chronic fatigue syndrome (CFS), also known as myalgic
encephalomyelitis (ME), an unexplained and devastating illness. It
manifests as not simply profound tiredness but also crippling pain,
especially after exercise, and a near paralysis of muscles that can
persist for days at a time. There is no known cure. It can last for
years, or decades, or the remainder of a life.

Sufferers are often confined to their rooms or beds, unable to walk.
It often appears to follow a viral infection, but no one knows why, or
what causes it; it is diagnosed only when the symptoms persist for a
period of months and no other cause is found.

Sophie Waterhouse was diagnosed with CFS/ME in 2010. First she had
glandular fever, or mononucleosis, an unpleasant viral infection that
is often followed by several months of profound fatigue. She was 30
years old at the time, and hugely active.

"I refused to accept I was ill," she told BuzzFeed News. "I carried on
doing triathlons and competitive racing. I carried on working hard and
partying hard."


And then, suddenly, she couldn't. "I couldn't move," she said. She had
to quit her job in recruitment. "I had a really successful job, a
really successful career," she said.

Less than a year later, she began the Lightning Process, a private
three-day course costing several hundred or sometimes thousands of
pounds. Its practitioners are keen to say it's not a treatment but a
training, and – in some cases – it has apparently removed the symptoms
of CFS/ME altogether. More than 20,000 people have used it worldwide,
according to its practitioners. Endorsements from the MOBO-winning
singer Laura Mvula and the former England rugby player Austin Healey
are prominent on the programme's website; elsewhere it links to a
glowing report by the TV presenter and Childline founder Esther
Rantzen, who says it rescued her daughter from 14 years of the
disease. (Rantzen also used it herself to prepare for her appearance
on the reality show I'm a Celebrity, Get Me Out of Here.)

The Lightning Process was developed by a British man, Phil Parker, in
the late 1990s. Parker is a former osteopath and hypnotherapist who
was once a teacher on a course that claimed to teach people how to
heal illnesses using spirit guides and tarot cards, but who is now
doing a PhD in health psychology.

The process, or its practitioners, have made some dramatic claims
about its effectiveness. At least one practitioner's website used to
say that it could "help you to completely recover permanently" from
CFS/ME with "no possibility of relapse", and that patients can
"achieve full recovery no matter how severe your symptoms are". Those
claims are now gone but are visible on web.archive.org, and were
recorded at the time by the charity Invest in ME.

Parker's own websites apparently used to make similar claims.
According to the charity 25% ME Group, Parker's website once said the
Lightning Process allowed patients "to automatically, easily and
effectively stop those thought patterns" that he said were "always
present" in ME. And lightningprocess.co.uk, which was described as
Parker's personal website, said it contained "stories of those who
inspired me with how they used the mind body connection to get over
ME/CFS, MS, Depression, Anxiety, Chronic Pain and Eating Disorders and
much more".

However, none of these claims are still available on the internet. The
Advertising Standards Agency (ASA) issued two rulings against Parker
and his companies in 2012 and 2013, saying his websites gave the
misleading impression that the Lightning Process could cure or treat
CFS/ME and other conditions. Other Lightning Process practitioners
have changed the claims on their websites following complaints to the
ASA – the most recent was just last month – that the ASA either upheld
or resolved informally. Parker told BuzzFeed News the claims on his
websites were "quite reasonable – we think the Lightning Process may
help some people with chronic fatigue, some of the time", and said it
was based on a survey of patients that found that 81.3% of patients
had improved, and anecdotal stories.

Despite this, until this year there were no scientific controlled
trials providing evidence for the process at all. But in September,
the first randomised controlled trial looking at the effectiveness of
the Lightning Process for CFS/ME was published. It appeared to show
that it did work for some young people. (In randomised controlled
trials – often described as the "gold standard" of medical research –
subjects are randomly divided, with half given the treatment and half
given a "control" treatment, to see which works better.)

The study, known as the SMILE trial, was widely publicised, mentioned
on BBC Radio 4's flagship news show the Today programme and in several
newspapers. One charity, the ME Association, told BuzzFeed News it had
seen a spike in discussion about the Lightning Process in the wake of
its publication.

But far from ending debate about the secretive therapy, the trial
inflamed it. Not one of the CFS/ME charities – Action for ME, the ME
Association, the 25% ME Group, ME Research UK, and Invest in ME –
BuzzFeed News has spoken to welcomed its findings; they were all
deeply wary. Several experts expressed profound concern over how the
trial was conducted.

BuzzFeed News spoke to the researcher behind the trial – who says she
has had death threats as a result – and five people who have used the
Lightning Process. Their experiences of it differed dramatically.

The details of what goes on in Lightning Process courses is not made
public – the website states little beyond the fact that mental
techniques, "postural exercises", and movements are taught in a
classroom style. Even the methods of the recent scientific trial do
not describe what it involves. But the patients we spoke to told very
similar stories, which also matched the stories of others on the
internet. It is based on a combination of osteopathy, hypnotherapy,
and "neuro-linguistic programming", or NLP.

"I was pretty nervous when I went in," said Paul (not his real name),
a 28-year-old journalist. "There were about seven of us, all looking
super decrepit. And you start doing this routine."

The routine involves putting mats on the floor, each with circles
drawn on them. "One had STOP written on it," said Joan McParland, a
Northern Irish woman and founder of Hope 4 ME & Fibro NI, a charity
for sufferers of CFS/ME and fibromyalgia. "And you say out loud,
'Stop, you have a choice.' And the next one says CHOICE, so you move
off STOP on to CHOICE.

"And then there are two circles in front of you: THE PIT and THE LIFE
YOU LOVE. So obviously you choose THE LIFE YOU LOVE."

As well as that, patients are encouraged to change the language they
used about their disease: "They tell you to stop talking about things
that 'I have' or that 'I am'," said Paul. "Instead of saying 'I'm
incredibly tired," you'd say 'I am doing fatigue.'" Then, he said, the
patient would "move to one side and say 'STOP' and try to do this
powerful physical stopping motion, which should give you some physical
sense of relief, or improvement."

Patients would also use vocal affirmations: Examples patients gave
BuzzFeed News included "I am a powerful genius" and "I am strong like
a tree". The process takes perhaps three minutes, and patients are
told to do it every time they feel their symptoms coming back.
McParland said: "You're told, 'Every time you have a negative thought,
say, Oh my god, I have no energy or I have dizziness or I can't get
out of the bed, get your circles out, get on the floor, say STOP to
the negative thoughts! Choose THE PIT or THE LIFE YOU LOVE, blah,
blah, and this is how you get cured."

As well as the process itself, patients are told about the theoretical
basis of the process. The idea is that the brain's "fight or flight"
response – the "physical emergency response" or PER, as the Lightning
Process website describes it – becomes hyperactive, causing it to
release too much adrenaline and interfere with the immune system. The
Lightning Process, according to its promotional material, teaches you
"how to spot when the PER is happening and how you can calm this
response down, allowing your body to re-balance itself".

Several people described the Lightning Process as "a cult", an
accusation Parker strongly denied to BuzzFeed News. "They brainwash
you," said Waterhouse. "Like a cult." "It is culty and very
dangerous," said McParland, who described it as "self-hypnosis". Even
Michael (not his real name), a man in his late thirties who says the
Lightning Process saved his life, said succinctly: "Looks culty, feels
culty." Paul, however, said it was "kooky" but that he didn't get the
sense of "cult-like piousness" that others had.

Patients report being told that they should keep quiet about the
process itself; a couple even say they were told to dissociate
themselves from people in their lives who are sceptical of it.

Jamie (not his real name), a man in his early thirties who was
diagnosed in 2009 after three years of illness, said: "We were told
that if we have friends who don't believe in the process, then maybe
don't associate with those friends any more, because they might be
stopping your recovery." McParland said she had been told that
"negative people in your life will bring you down", and had been
warned not to start the patients' charity she dreamed of founding.
Waterhouse said: "They told you not to talk to anyone about it, not to
show them what the process is. It would inhibit your desire to do it
because people might be sceptical."

Parker denies that Lightning Process practitioners do this. "That
would be crazy," he said. "If you're doing something that you're
excited about and people are super negative about it, maybe you'll go
'I won't talk to them about it', but we'd never say 'divorce your
wife'."

Some patients also say they are blamed for their own failure to get
better. "They tell you it's your fault if it doesn't work," said
McParland. This is not a new accusation: Some of the young patients
spoken to in a qualitative study of the Lightning Process published in
2012 reported "feelings of being blamed if the treatment didn't work".

Again, Parker strenuously denies this. However, application forms for
the Lightning Process reportedly used to include the disclaimers "I
accept full responsibility for the effects of applying or not applying
the Lightning Process to my life" and "I understand that learning the
Lightning Process in itself does not guarantee me good results,
because I alone am responsible for applying or not applying it".

Now the application forms have a much more toned-down version: "It is
then up to the student to apply the lessons for themselves in order to
achieve the benefits. If the student doesn't apply the training, then
they will naturally see very little benefit." However, the old version
is still partially visible in cached Google results on a
practitioner's site.

Jamie raised another concern. One of the other patients at the clinic
he went to in 2009 didn't have CFS/ME but multiple sclerosis, a
disease of the nervous system that can lead to severe disability. "The
thing that sticks in my mind, because I was so disgusted by it, was
the sight of the guy with MS struggling to jump around on the mat,
half in tears
, doing a jump, saying to himself 'I'm strong like a
tree'," Jamie said.

Claiming to be able to treat many different conditions with the same
treatment is often a sign of pseudoscience, Dr Charles Shepherd, the
medical adviser to the ME Association charity, told BuzzFeed News. "In
all seriousness, if the Lightning Process can treat and restore people
with depression, tics, Tourette's, multiple sclerosis,
obsessive-compulsive disorder, the list goes on, in a matter of three
days – it's Nobel Prize material. The NHS would save billions."


Parker said Lightning Process practitioners do work with people who
have MS, but that they don't claim it works for everyone. "If you have
MS and are wondering whether the Lightning Process can fix it, I would
say, 'Well, we've had some success in the past, but also some people
have had no change whatsoever.' So maybe there's something going on
here, but there's no guarantee it will make a difference."

It's easy to see why the promise of the Lightning Process is so
appealing to people with CFS/ME. "They give you buckets of hope,"
McParland said. "They hype you up so much. And with this disease, you
don't have much hope."

McParland had been ill for a long time. "At that stage I was about 10
or 12 years sick," she said. In October 1999 she had a viral illness,
and it led to ME. "You never recover." So around 2011, she heard of
the Lightning Process through word of mouth, and got in touch. She was
called back soon afterwards. "We were told we'd have a life-changing
weekend," she said. "They know all the right buzzwords to say.

"They're very good on the phone, and by the time you've finished the
15-minute phone call you're all geed up that you're going to get
better." The phone call is not just selling the Lightning Process to
the potential patient; "it's to see if you're a suitable candidate"
for the treatment, said McParland.

Waterhouse's experience sounds similar. "You're willing to try
anything," she said. "You're in an incredibly vulnerable state. You're
desperate, because every doctor is turning you away and can't help
you.

"And these people tell you that they can help you, when you're at your
absolute worst."

BuzzFeed News also heard two stories of remarkable recovery after the
Lightning Process. Michael, who works in the media, underwent it in
2007. He had been confined to a darkened room, hypersensitive to
light; he lacked the strength to walk, and had contemplated suicide,
having heard stories of people being sick with CFS/ME for decades.

The Lightning Process, he said, turned him around, almost immediately.
"It made me better," he told BuzzFeed News. "Better than I was
before." He had suffered from depression and anxiety before being
struck down with CFS/ME; now his depression is gone and his anxiety,
he said, is "minimal".

Paul said something similar. "It had an effect within a couple of
days," he told BuzzFeed News. When he went along for treatment, about
two and a half years ago, he had been bedridden for months; he was
living with his parents. "I'd got this weird thing where my legs kind
of stopped being able to function when I walked," he said. He, like
Michael, had been terrified of the disease lasting the rest of his
life: "The internet is full of horrible, horrible stories about
chronic fatigue," he said. "About how it can last forever, about how
people have it for years and years and years."

But after his first day of the Lightning Process, he left the building
on foot. Two weeks after the end of the course, he went back to work.
Would he use the word "cured", BuzzFeed News asked? "Yeah," he said,
"100% cured."

Positive stories of recovery like these are all over the Lightning
Process website, and the websites of licensed practitioners. The
site's "research" page includes the survey that found 81.3% of
patients report improvement. And as of September this year, the
process's promotional materials have included the more formal
scientific study that changed everything: the SMILE trial.

The story of the SMILE trial began in 2010, when Professor Esther
Crawley of the University of Bristol got permission to carry out a
randomised controlled trial into the Lightning Process. She looked at
the "clinical and cost-effectiveness of the Lightning Process" in
children with CFS/ME, taking about 100 young people and dividing them
up at random into two groups. One group had standard medical care, and
one had standard medical care plus the Lightning Process. The study
found that children who also had the Lightning Process reported better
physical function and school attendance than those who just had
standard care. It also found that these improvements lasted – the
children were followed up after a year, and were still doing better.

But charities have been concerned about the study from the start, they
have told BuzzFeed News. First, several patients and charities said it
was unethical to do the first trial of an untested procedure on
children. A spokesperson for 25% ME Group told BuzzFeed News: "We are
definitely 100% against the SMILE trial. We are extremely worried
about what they're doing with children in this area." They expressed
concern when the trial was proposed as did other charities including
the Young ME Sufferers (TYMES) Trust and the ME Association. Crawley
says she doesn't understand why the charities are so negative, but
that the children in her clinic and their parents were keen that the
trial be done.

There has been historical mistrust of research into CFS/ME, including
controversy over another divisive trial, a study into "graded exercise
therapy" that helped lead to the NHS recommending that therapy for
CFS/ME sufferers. The PACE trial, as it was known, was savagely
criticised by some patients and academics amid accusations of bad
trial design and other poor practices. The trial's authors still stand
by it, as does the Lancet journal that published it in 2011.

When the SMILE study was published, many had similar concerns. John
Edwards, professor emeritus of connective tissue disease at University
College London, told BuzzFeed News the fundamental problem was that
the research was "unblinded, with a subjective outcome".

In the highest-quality medical trials, subjects are "blinded" – they
don't know whether they're getting the treatment that's being tested,
or what it's being tested against. It helps stop the results being
biased in favour of the treatment. If you can't blind the trial, said
Edwards, then it's important to ensure that you measure something that
can't be affected by patients' perceptions. "You can have an unblinded
trial and measure everyone's blood sodium concentration at the end,"
he said. "They can't do anything to their sodium concentration, so it
doesn't matter if they know whether they're getting the treatment or
not.

"And the other way around is fine: If you blind everything so they
patients don't know if they've had the treatment, then you can use a
subjective measure. But you can't have an unblinded trial and a
subjective outcome." But the SMILE trial was unblinded, and the
outcomes – which initially were intended to include an objective
measure, school attendance – were changed after the initial proposal
to a questionnaire. Edwards said such self-reported measures are often
prone to bias, as subjects give the answers they think they are
expected to give. For that reason, he believes, the trial is
"useless".

The problem was, in some eyes, made worse by the fact that
the methods
of the Lightning Process involve making people say that they feel
better. "All this trial shows is that if you tell people to say
they're better, and then ask them if they're better, they'll say
they're better,"
said Edwards. "It's a textbook case of how not to
design a trial."

He claims the SMILE trial's results also undermine the PACE trial –
which also used an unblinded trial with subjective outcomes – by
showing that "the same techniques can get you the same answer for a
completely quack therapy based on complete nonsense like standing on
pieces of paper and telling your disease to stop".

In response, Parker told BuzzFeed News that "pejorative labels such as
'quack' [are] well past their sell-by date" given that the Lightning
Process "has been shown, via a peer-reviewed RCT, to have some
efficacy", and that "a number of medical doctors and researchers have
observed the Lightning Process – their opinion has been completely the
opposite and said that it is based on sound understanding of anatomy,
physiology and neuroscience".

Dorothy Bishop, a professor of developmental neuropsychology at the
University of Oxford, told BuzzFeed News she was also concerned about
the "wisdom of running a trial [into something] that doesn't seem to
have much scientific basis and is commercial, because if you find a
result you end up giving huge kudos to something that may not deserve
it".

"I don't want to come down like a ton of bricks on Esther Crawley
because I think she's doing her best," she said, but she was concerned
about a "a mega-placebo effect".

Crawley told BuzzFeed News it was possible that there was some placebo
effect involved, but that the questionnaires she used in the trial
asked questions about how far you can walk and how much school you
attended, rather than simply whether people felt better. She added
that self-reported school attendance lined up very well with the
schools' records of attendance.

The SMILE trial appears to have had concerning effects for Crawley
personally. The University of Bristol has said she has experienced
"significant harassment and personal abuse over several years",
including "blogs/tweets and other social media posts that could be
regarded as defamatory". Crawley has claimed in the press that she has
received death threats.

It's far from the first time that research around CFS/ME has led to
claims of harassment. One researcher, who wished to remain anonymous,
told BuzzFeed News: "The last time I said anything public about CFS, I
got followed around by an angry mob for about a year, on Twitter and
email. Some even turned up to talks I gave, and I've heard of them
turning up to people's houses or doxxing them."

The campaigning journalist and academic David Tuller of the University
of California at Berkeley – who has written for BuzzFeed in the past –
has written lengthy blog posts claiming Crawley's research was flawed.

He told BuzzFeed News that Crawley had accused him of libel and
harassment. A photo shared on social media of Crawley giving a talk
showed a slide saying "libellous blogs", with a screenshot of one of
Tuller's posts. In audio of the Q&As of another talk, heard by
BuzzFeed News, Tuller asks her how he had libelled her and Crawley can
be heard telling him he had been "unbelievably defamatory and
unprofessional". Crawley declined to talk about the issue when asked
by BuzzFeed News.

Tuller denied to BuzzFeed News that he had been libellous or
threatening, although he admitted being rude. "Just because she finds
what I've written offensive and obnoxious, that doesn't mean that it's
libellous," he said. "It just means she finds it offensive and
obnoxious."

The University of Bristol told BuzzFeed News that "private and
confidential communication has taken place at a senior level between
the two universities" regarding Tuller's behaviour. Professor Arthur
Reingold, Tuller's superior at Berkeley, confirmed that this was the
case, saying: "Both UC Berkeley and the University of Bristol believe
strongly in the principles of academic freedom and the ability to
engage in robust scientific debate. The two universities are also
interested in seeing that such debates occur in a civil manner so that
the genuine issues of scientific discovery and research methods are
not lost in arguments of a personal nature."

Tuller says this is an attempt to shut down academic freedom to
criticise other researchers' work. Edwards, a former colleague of
Crawley's, told BuzzFeed News the letter "raises serious concerns
about the probity of the University of Bristol". Bristol said it
didn't feel it was appropriate to comment on this.

A freedom of information request by the TYMES Trust revealed that
Bristol didn't have any records of harassment against Crawley,
although the university stressed that it was aware of such harassment
and the lack of records simply reflected that it didn't have a process
for recording it.

In the years since their Lightning Process attendance, the patients
BuzzFeed spoke to have had very different experiences. "You leave
thinking, This is amazing, it's all been in my head," said Waterhouse.
"And I went back to living my life as much as I could. I'd have
another drink because they're telling me it's all in my head. I pushed
my body beyond where it should have gone.

"And I believe that has been detrimental to me still suffering from ME
nine years on, because the advice should be to pull everything back,
to rest."

McParland similarly says it led to a crash.
"You come home on this
high, and you do try and do things that you didn't normally do," she
said. "You do them for about one to two weeks, and then bang, back to
square one. Even worse, because you've done more than you ever did."

Exactly why it appears to work for some people but not others is
obviously not clear, but
one possibility that the patients raised is
that they actually had different conditions. McParland suggests that
there are people who are being misdiagnosed with CFS/ME, but who in fact have depression or anxiety, and that perhaps this explains why it has an effect in some people. Edwards agrees. "In my career looking at rheumatoid arthritis, you'd get a lot of people who thought they had it but didn't," he said. "But with conditions like rheumatoid
arthritis it's quite easy to tell who really has it. With ME you can't."


Peter Rowe, a professor of pediatrics at the John Hopkins University
School of Medicine in Baltimore, told BuzzFeed News it was
"preposterous" to suppose his CFS/ME patients could get better in
three days. He thinks the diagnostic criteria in the UK, under which
children can be diagnosed with CFS/ME if they've been ill for three
months, and adults for four, brings a lot of people with other
conditions – including depression, anxiety, and glandular fever –
under the umbrella of CFS/ME. In the US, diagnosis can't happen until
six months.

"Having seen people in a specialist clinic for the last 23 years," he
said, "I've never seen anyone who had true ME/CFS who could get better
in a weekend. It raises the question of what these folks had when they
report such a massive turnaround." He thinks that since a lot of
people with glandular fever get better spontaneously between three and
six months after falling ill, that might also partly explain the
phenomenon.


All the patients BuzzFeed News spoke to said the Lightning Process
treats CFS/ME as a mental illness, rather than a physical one. (Parker
denies this characterisation.)

The difference was that the two for whom it worked agreed it was a
mental illness. "I fundamentally believe that it is a psychological
condition," said Paul. "I know that's really controversial, but I
think that [the Lightning Process] has hit on something that it really
is like a pattern in your brain that keeps you feeling like your body
is constantly attacking itself, and you can flip a switch that stops
it doing that." Michael describes CFS/ME as a "physical manifestation
of a psychological illness".

But McParland, Waterhouse, and Jamie disagreed. "I'd have loved it if
it was a mental illness," said Waterhouse. "I'd have done the
Lightning Process for the rest of my life it had worked."

Parker said the Lightning Process has had success with many people who
have been sick for years, some of whom are tube-fed and bedridden. He
added that "one of the ironies is that the argument with chronic
fatigue is that people don't take the disease seriously, but the
moment people get well, suddenly people say 'well you didn't really
have it'."

Life for the patients who told BuzzFeed News they continue to have
symptoms after the Lightning Process is a struggle. McParland said her
"life ended at 44"; nearly two decades later, she still had to do
relaxation exercises before speaking to BuzzFeed News on the phone.
Jamie still struggles with fatigue and poor sleep and other problems.
"I've learned to function around them," he said, but he had to quit a
stressful job last year because the work was making him worse.

Waterhouse said her "whole life has changed" as a result of her
illness; she said she is still single because of it, and hasn't worked
for two years, since having a "massive crash" after trying to set up
her own business. Not only did the process not help her, she considers
it to be cruel.

"I just think it's really unfair," she said. "Telling people who have
a debilitating condition such as ME that it's all in our minds, and
that we should try harder. I'm the last person in the world who should
try harder. That's where it's totally wrong."